Venlafaxine prolonged-release Krka 37.5 mg hard capsules prolonged-release

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Venlafaxine retard Krka 37.5 mg prolonged-release hard capsules

venlafaxine hydrochloride

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Venlafaxine retard Krka is and what it is used for
2. What you need to know before taking Venlafaxine retard Krka
3. How to take Venlafaxine retard Krka
4. Possible side effects
5. How to store Venlafaxine retard Krka
6. Contents of the pack and other information

1. What Venlafaxine Retard Krka is and what it is used for

Venlafaxine Retard Krka contains the active substance venlafaxine.

Venlafaxine Retard Krka is an antidepressant that belongs to a group of medicines known as serotonin and norepinephrine reuptake inhibitors (SNRIs). This group of medicines is used to treat depression and other conditions such as anxiety disorders. It is believed that people who are depressed and/or suffer from anxiety have lower levels of serotonin and norepinephrine in the brain. The exact way antidepressants work is not fully understood, but they may help increase the levels of serotonin and norepinephrine in the brain.

Venlafaxine Retard Krka is a treatment for depression in adults. Venlafaxine Retard Krka is also a treatment for the following anxiety disorders in adults: generalized anxiety disorder, social anxiety disorder (fear or avoidance of social situations), and panic disorder (panic attacks). Properly treating depressive and anxiety disorders is important to help you feel better. If left untreated, your condition may not resolve or may worsen and become more difficult to treat.

2. What you need to know before taking Venlafaxine retard Krka

Do not take Venlafaxine retard Krka

• If you are allergic to venlafaxine or to any of the other ingredients of this medicine (listed in section 6).
• If you are currently taking or have taken at any time within the last 14 days a medicine known as an irreversible monoamine oxidase inhibitor (MAOI), used to treat depression or Parkinson's disease. Taking an irreversible MAOI together with Venlafaxine retard Krka may result in serious or even potentially fatal adverse effects. In addition, you must wait at least 7 days after stopping Venlafaxine retard Krka before starting any irreversible MAOI (see also the section titled “Other medicines and Venlafaxine retard Krka” and the information in that section regarding “Serotonin syndrome”).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Venlafaxine retard Krka:

• If you are taking other medicines that, when taken together with Venlafaxine retard Krka, could increase the risk of developing serotonin syndrome (see section “Other medicines and Venlafaxine retard Krka”)
• If you have eye problems, such as certain types of glaucoma (increased pressure in the eye)
• If you have a history of high blood pressure
• If you have a history of heart problems
• If you have been told that your heart rhythm is abnormal
• If you have a history of seizures (fits)
• If you have a history of low sodium levels in the blood (hyponatremia)
• If you are prone to bruising or have a tendency to bleed easily (history of bleeding disorders), if you are pregnant (see Pregnancy, breastfeeding and fertility), or if you are taking other medicines that may increase the risk of bleeding, e.g., warfarin (used to prevent blood clots)
• If your cholesterol levels increase
• If you have a history of, or if someone in your family has had, mania or bipolar disorder (feeling overly excited or euphoric)
• If you have a history of aggressive behavior

Venlafaxine retard Krka may cause a feeling of restlessness or difficulty sitting or staying still during the first weeks of treatment. You should consult your doctor if this occurs.

Do not drink alcohol during treatment with venlafaxine, as it may cause extreme drowsiness and unconsciousness. Taking it together with certain medicines and/or alcohol may worsen symptoms of depression and other conditions, such as anxiety disorders.

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of harming yourself or of suicide. These thoughts may increase when you first start taking antidepressants, because all these medicines take time to work—usually about two weeks, but sometimes longer. These thoughts may also occur when your dose is reduced or during discontinuation of treatment with Venlafaxine retard Krka.

This is more likely to happen:

• If you have previously had thoughts of suicide or of harming yourself.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in young adults (under 25 years of age) with psychiatric disorders treated with antidepressants.

If you have thoughts of harming yourself or of suicide at any time, contact your doctor or go to a hospital immediately.

It may be helpful to tell a close friend or family member that you are depressed or have an anxiety disorder and ask them to read this leaflet. You may also ask them to inform you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behavior.

Sexual dysfunction

Some medicines in the group to which Venlafaxine retard Krka belongs (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Dry mouth

Dry mouth has been reported in 10% of patients treated with venlafaxine. This may increase the risk of dental caries. Therefore, you should take care with your dental hygiene.

Diabetes

Blood glucose levels may be altered by Venlafaxine retard Krka. Therefore, it may be necessary to adjust the dosage of your diabetes medications.

Children and adolescents

Venlafaxine retard Krka should not normally be used in the treatment of children and adolescents under 18 years of age. In addition, you should know that in patients under 18 years of age there is an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe this medicine to patients under 18 years of age if they decide it is in the patient’s best interest. If your doctor has prescribed this medicine to a patient under 18 years of age and you wish to discuss this decision, please return to your doctor. You should inform your doctor if any of the above-mentioned symptoms develop or worsen while these patients under 18 years of age are taking Venlafaxine retard Krka. In addition, the long-term effects on safety and on growth, maturation, and cognitive and behavioral development of this medicine have not yet been established.

Other medicines and Venlafaxine retard Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Your doctor must decide whether you can take Venlafaxine retard Krka with other medicines.

Do not start or stop taking any medicine, including those available without a prescription, natural remedies, or herbal products, without first checking with your doctor or pharmacist.

• Monoamine oxidase inhibitors used to treat depression or Parkinson's disease must not be taken with Venlafaxine retard Krka. Inform your doctor if you have taken these medicines within the last 14 days. (MAOI: see section “What you need to know before taking Venlafaxine retard Krka”).

• Serotonin syndrome: a potentially life-threatening condition or reactions consistent with neuroleptic malignant syndrome (NMS) (see section “Possible side effects”) may occur with venlafaxine treatment, particularly when taken with other medicines. Examples of such medicines include:

• triptans (used for migraine)

• other medicines to treat depression, e.g., SNRIs, SSRIs, tricyclic antidepressants, or medicines containing lithium

• medicines containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity)

• medicines containing the antibiotic linezolid (used to treat infections)

• medicines containing moclobemide, a reversible MAOI (used to treat depression)

• medicines containing sibutramine (used for weight loss)

• medicines containing opioids (e.g., buprenorphine, tramadol, fentanyl, tapentadol, meperidine, or pentazocine) used to treat severe pain

• medicines containing dextromethorphan (used to treat cough)

• medicines containing methadone (used for opioid addiction treatment or for treatment of severe pain)

• medicines containing methylene blue (used to treat elevated levels of methemoglobin in blood)

• products containing St. John's wort (also known as “Hypericum perforatum”, a natural or herbal remedy used to treat mild depression)

• products containing tryptophan (used for problems such as sleep and depression)

• antipsychotics (used to treat a disease with symptoms such as hearing, seeing, or feeling things that do not exist, false beliefs, unusual suspicion, lack of clarity in reasoning, and withdrawal syndrome).

Signs and symptoms of serotonin syndrome may include a combination of the following: restlessness, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, hyperactive reflexes, diarrhea, coma, nausea, vomiting.

In its most severe form, serotonin syndrome may resemble neuroleptic malignant syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, acute muscle rigidity, confusion, and increased muscle enzymes (determined by blood test).

Contact your doctor immediately, or go to the nearest hospital emergency department if you think you are experiencing serotonin syndrome.

Inform your doctor if you are taking medicines that may affect your heart rhythm.

Some examples of these medicines include:

• Antiarrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used to treat abnormal heart rhythm)
• Antipsychotics such as thioridazine (see also serotonin syndrome above)
• Antibiotics such as erythromycin or moxifloxacin (used to treat bacterial infections)
• Antihistamines (used to treat allergy)

The following medicines may also interact with Venlafaxine retard Krka and should be used with caution. It is especially important to inform your doctor or pharmacist if you are taking medicines containing:

• Ketoconazole (an antifungal medicine)
• Haloperidol or risperidone (to treat psychiatric conditions)
• Metoprolol (a beta-blocker used to treat high blood pressure and heart problems)

Taking Venlafaxine retard Krka with food, drinks, and alcohol

Venlafaxine retard Krka should be taken with food (see section 3 “How to take Venlafaxine retard Krka”).

Do not drink alcohol during treatment with venlafaxine. Taking it together with alcohol may cause extreme drowsiness and unconsciousness, and may worsen symptoms of depression and other conditions such as anxiety disorders.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. You should only take Venlafaxine retard Krka after discussing with your doctor the potential benefits and potential risks to the unborn child.

If you take Venlafaxine retard Krka in the late stages of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking Venlafaxine retard Krka so they can advise you.

Ensure that your midwife and/or doctor knows you are being treated with Venlafaxine retard Krka. When taken during pregnancy, similar medicines (SSRIs) may increase the risk of serious conditions in newborns called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and appear blue. These symptoms usually begin within the first 24 hours of the baby’s life. If this happens to your baby, contact your midwife and/or doctor immediately.

If you are taking this medicine during pregnancy, in addition to breathing problems, other symptoms your baby may have at birth include feeding difficulties. If your baby has these symptoms at birth and you are concerned, contact your doctor and/or midwife, who can advise you.

Venlafaxine retard Krka passes into breast milk. There is a risk of effects on the baby. Therefore, you should discuss the situation with your doctor, who will decide whether you should discontinue breastfeeding or discontinue treatment with this medicine.

Driving and using machines

Do not drive or operate tools or machinery until you know how Venlafaxine retard Krka affects you.

Venlafaxine retard Krka contains sucrose

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Venlafaxine retard Krka

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The usual recommended starting dose for the treatment of depression, generalized anxiety disorder, and social anxiety disorder is 75 mg daily. Your doctor may gradually increase the dose, and if necessary, even up to a maximum dose of 375 mg daily for depression. If you are being treated for panic disorder, your doctor will start you on a lower dose (37.5 mg) and subsequently increase the dose gradually. The maximum dose for generalized anxiety disorder, social anxiety disorder, and panic disorder is 225 mg/day.

Take Venlafaxine retard Krka at approximately the same time each day, either in the morning or in the evening. The capsules must be swallowed whole with liquid and must not be opened, crushed, chewed, or dissolved.

Venlafaxine retard Krka should be taken with food.

If you have liver or kidney problems, speak with your doctor, as your dose of this medicine may need to be adjusted.

Do not stop taking this medicine without consulting your doctor (see section “If you stop taking Venlafaxine retard Krka”).

If you take more Venlafaxine retard Krka than you should

Contact your doctor or pharmacist immediately if you take more of this medicine than prescribed. You may also contact the toxicology information service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

Overdose can be life-threatening, especially when taken simultaneously with certain medicines and/or alcohol (see Other medicines and Venlafaxine retard Krka).

Symptoms of a possible overdose may include palpitations, changes in level of consciousness (ranging from drowsiness to coma), blurred vision, seizures or fits, and vomiting.

If you forget to take Venlafaxine retard Krka

If you have missed a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next dose at the usual time. Do not take a double dose to make up for a forgotten dose. Do not take more than the daily amount of Venlafaxine retard Krka prescribed for you in one day.

If you stop taking Venlafaxine retard Krka

Do not stop taking your treatment or reduce the dose without the advice of your doctor, even if you feel better. If your doctor considers that you no longer need Venlafaxine retard Krka, they may ask you to gradually reduce the dose before stopping treatment completely. Adverse effects are known to occur when people stop using this medicine, especially when it is stopped suddenly or the dose is reduced too quickly. Some patients may experience symptoms such as suicidal thoughts, aggression, fatigue, dizziness, lack of coordination, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, tinnitus, tingling sensations, or, less commonly, electric shock-like sensations, weakness, sweating, seizures, flu-like symptoms, visual disturbances, and increased blood pressure (which may cause headache, dizziness, tinnitus, sweating, etc.).

Your doctor will advise you on how to gradually discontinue treatment with Venlafaxine retard Krka. This process may take several weeks or months. In some patients, discontinuation may need to occur very gradually over months or longer. If you experience any of these or other bothersome symptoms, consult your doctor for further advice.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If any of the following effects occur, stop taking Venlafaxine Retard Krka and contact your doctor immediately or go to the nearest hospital emergency department:

Uncommon (may affect up to 1 in 100 people)

• Swelling of the face, mouth, tongue, throat, hands or feet and/or swollen itchy rash, difficulty swallowing or breathing.

Rare (may affect up to 1 in 1,000 people)

• Chest tightness, wheezing, difficulty swallowing or breathing.
• Severe skin rash, severe itching or severe hives (raised red or pale areas of skin, often itchy).
• Signs and symptoms of serotonin syndrome, which may include restlessness, hallucinations, lack of coordination, rapid heart rate, increased body temperature, rapid changes in blood pressure, hyperactive reflexes, diarrhea, coma, nausea, vomiting.

In its most severe form, serotonin syndrome may resemble neuroleptic malignant syndrome (NMS).

Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, and increased muscle enzymes (detected by a blood test).

• Signs of infection, such as increased temperature, chills, shivering, headache, sweating, or flu-like symptoms. This may be due to a blood disorder that can lead to an increased risk of infection.
• Severe rash, which may progress to the formation of severe blisters and peeling of the skin.
• Unexplained muscle pain, discomfort, or weakness. This may be a sign of rhabdomyolysis.

Frequency not known (cannot be estimated from available data)

• Signs and symptoms of a condition called “stress cardiomyopathy” (also known as Takotsubo cardiomyopathy), which may include chest pain, difficulty breathing, dizziness, fainting, or irregular heartbeats.

Other side effects about which you should inform your doctor (the frequency of these adverse effects are included in the list below “Other adverse effects that may occur”) include:

• Cough, noisy breathing, and difficulty breathing, which may be accompanied by increased temperature.
• Black (tarry) stools or blood in the stools.
• Itching, yellowing of the eyes or skin, dark urine, which may be symptoms of liver inflammation (hepatitis).
• Heart problems, such as rapid or irregular heartbeat, increased blood pressure.
• Eye problems, such as blurred vision, dilated pupils.
• Nervous system problems: such as dizziness, tingling, movement disorders (muscle spasms and stiffness), seizures or fits.
• Psychiatric problems, such as hyperactivity (unusual feeling of over-excitement).
• Withdrawal effects (see section “How to take Venlafaxine Retard Krka”, “If you stop taking Venlafaxine Retard Krka”).
• Prolonged bleeding time: if you cut yourself or are injured, bleeding may take longer than normal to stop.

Other adverse effects that may occur

Very common (may affect more than 1 in 10 people)

• Dizziness, headache, drowsiness.
• Insomnia.
• Nausea, dry mouth, constipation.
• Sweating (including night sweats).

Common (may affect up to 1 in 10 people)

• Decreased appetite.
• Confusion, feeling detached from oneself, inability to achieve orgasm, decreased libido, agitation, restlessness, abnormal dreams.
• Tremor, a feeling of restlessness or inability to sit still or remain motionless, tingling, altered taste perception, increased muscle tone.
• Visual disturbances including blurred vision, dilated pupils, inability of the eye to automatically adjust focus from distant to near objects.
• Ringing in the ears (tinnitus).
• Fast heartbeat, palpitations.
• Increased blood pressure, hot flushes.
• Difficulty breathing, yawning.
• Vomiting, diarrhea.
• Mild skin rash, itching.
• Increased frequency of urination, inability to urinate, difficulty urinating.
• Menstrual irregularities, such as increased or irregular bleeding, abnormal ejaculation/orgasm (in men), erectile dysfunction (impotence).
• Weakness (asthenia), fatigue, chills.
• Weight gain or weight loss.
• Increased cholesterol.

Uncommon (may affect up to 1 in 100 people)

• Hyperactivity, racing thoughts, and reduced need for sleep (mania).
• Hallucinations, feeling detached from reality, abnormal orgasm, lack of feelings or emotions, feeling overexcited, teeth grinding.
• Fainting, involuntary muscle movements, impaired coordination and balance.
• Dizziness (especially when standing up too quickly), decreased blood pressure.
• Vomiting blood, tarry stools (faeces), or blood in the stools, which may be a sign of internal bleeding.
• Sensitivity to sunlight, bruising, abnormal hair loss.
• Inability to control urination.
• Muscle stiffness, spasms, and involuntary muscle movements.
• Slight changes in blood levels of liver enzymes.

Rare (may affect up to 1 in 1,000 people)

• Seizures or fits.
• Cough, noisy breathing, and shortness of breath, which may be accompanied by high temperature.
• Disorientation and confusion, often accompanied by hallucinations (delirium).
• Excessive water intake (known as SIADH).
• Decreased levels of sodium in the blood.
• Severe eye pain and reduced or blurred vision.
• Abnormal, fast or irregular heartbeat, which may lead to fainting.
• Severe abdominal or back pain (which may indicate a serious problem in the intestine, liver, or pancreas).
• Itching, yellowing of the eyes or skin, dark urine, flu-like symptoms, which are signs of liver inflammation.

Very rare (may affect up to 1 in 10,000 people)

• Prolonged bleeding, which may be due to a low number of platelets in the blood, leading to increased bruising or bleeding.
• Abnormal production of breast milk.
• Unexpected bleeding, for example, bleeding from the gums, blood in urine or vomit, or the appearance of bruises or broken blood vessels (ruptured veins).

Frequency not known (cannot be estimated from available data)

• Suicidal thoughts and suicidal behaviour; cases of suicidal thoughts and behaviour have been reported during treatment with venlafaxine or shortly after discontinuation of treatment (see section 2. “What you need to know before starting to take Venlafaxine Retard Krka”).
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see “Pregnancy, breastfeeding and fertility” in section 2 for further information.
• Aggression.
• Dizziness.

Venlafaxine Retard Krka sometimes causes unwanted effects that you may not be aware of, such as increases in blood pressure or an abnormal heartbeat; slight changes in blood levels of liver enzymes, sodium, or cholesterol. Less frequently, Venlafaxine Retard Krka may reduce the function of blood platelets, leading to an increased risk of bruising or bleeding. Therefore, your doctor may wish to carry out occasional blood tests, particularly if you have been taking Venlafaxine Retard Krka for a long time.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Venlafaxine Krka prolonged release

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the container, after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Venlafaxine retard Krka

• The active substance is venlafaxine. Each prolonged-release hard capsule contains 37.5 mg of venlafaxine as venlafaxine hydrochloride.
• The other components are: sugar spheres (sucrose, maize starch), hydroxypropylcellulose (E463), povidone K30 (E1201), ethylcellulose, dibutyl sebacate and talc (E553B).
• Components of the capsule shell: gelatin, iron oxide red (E172) and titanium dioxide (E171). See section 2 "Venlafaxine retard Krka contains sucrose".

Appearance of the product and contents of the pack

Prolonged-release hard capsule.

Brownish-pink and white capsules (white body and brownish-pink cap) containing white to off-white spheres.

Pack sizes:

Blister packs containing 7, 10, 14, 20, 28, 30, 50, 60, 98, 100 and 112 prolonged-release hard capsules.

HDPE bottles with child-resistant closure containing 50, 100 or 250 prolonged-release hard capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For further information about this medicinal product, please contact the Marketing Authorization Holder's Local Representative:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Date of the most recent review of this leaflet: May 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es